Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005795
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2000-06-02
Brief Title:
Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Acute Myeloid Leukemia Secondary Leukemia andor Newly-Diagnosed Patients Greater Than or Equal to 65 Years Old
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have acute myeloid leukemia
Detailed Description:
OBJECTIVES I Determine the rate of response complete or partial remission duration of response relapse free survival and overall survival of patients with relapsed or refractory acute myeloid leukemia AML or untreated older patients or those with secondary AML when treated with arsenic trioxide II Evaluate the toxicities of this agent in this patient population III Measure degree of apoptosis induced andor differentiation in pretreatment and posttreatment AML cells
OUTLINE Patients receive arsenic trioxide IV over 1-4 hours daily for up to 60 days or until bone marrow blasts are less than 5 followed by 4-6 weeks of rest After the first course additional courses of arsenic trioxide last 25 days Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Patients with a complete response CR receive 1 additional 25 day course after achieving CR Patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 12 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 2 years
OUTLINE Patients receive arsenic trioxide IV over 1-4 hours daily for up to 60 days or until bone marrow blasts are less than 5 followed by 4-6 weeks of rest After the first course additional courses of arsenic trioxide last 25 days Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Patients with a complete response CR receive 1 additional 25 day course after achieving CR Patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 12 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0094 | None | None | None |
| NU-99H6 | None | None | None |
| NU-476-016 | None | None | None |